• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG CHPV WITH SG

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTEGRA LIFESCIENCES SWITZERLAND SAR PROG VALVE INLINE W SG CHPV WITH SG Back to Search Results
Catalog Number 823832
Device Problem Fluid Leak (1250)
Patient Problem Failure of Implant (1924)
Event Date 12/14/2021
Event Type  Injury  
Event Description
A facility reported that after a hakim valve was implanted, water was leaking between the valve and siphon-guard; therefore it was explanted and replaced with another same device. The event led to 10 minutes surgical delay.
 
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROG VALVE INLINE W SG
Type of DeviceCHPV WITH SG
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
ch-2400
le locle
SZ
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key13117032
MDR Text Key282956333
Report Number3013886523-2021-00573
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K053107
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number823832
Device Lot Number4582714
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received02/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-